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Job description

**Role & responsibilities** 1. Optimization of the Quality Assurance function, ensuring that the pharmacovigilance (PV) & clinical trial (CT) activities are conducted in compliance with internal procedures, regulatory requirements and industry standards. 2. Development of policies/SOPs for quality assurance activities of PV & CT. 3. Development of risk based strategic and tactical audit plan as required. 4. Plan and conduct internal PV system audit, affiliates audit, licensing partners audit and service provider audit in support of global PV activity for post marketed and clinical development products, to assure compliance with the US Code of Federal Regulations, EU Directives, local regulations, ICH and Alkem policies and procedures. 5. Plan and conduct internal audit of clinical research team and audit of clinical trial at investigator site in support of clinical development products for Phase 3 and 4, to assure compliance with the US Code of Federal Regulations, EU Directives, local regulations, ICH and Alkem policies and procedures. 6. Support to facilitate timely PV and CT audit responses and evaluate proposed corrective actions, and/or preventative actions, including effectiveness checks for compliance with applicable regulations, guidelines, and Alkem policies and procedures. 7. Support for global inspection activities, including inspection preparation and inspection management, in close collaboration with Corporate Quality Assurance and Compliance team. 8. Support in the preparation, hosting and follow-up audits from licensing partners. Provide audit response and CAPA to the licensing partners. 9. Support the ongoing development and operational success of the medical quality assurance functions. 10. Ensuring the reports and appropriate (corrective and/or preventive) actions are developed and completed within timelines mandated in internal procedures **Education Qualification** - Masters degree or equivalent within Pharmacy, science or similar **Years Of Experience** - 2-5 years of experience working in a Pharmaceutical or CRO setting (or equivalent); with mandatory GCP/PV auditing experience